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| Name | Class |
|---|---|
| Nanjing Bioheng Biotech Co., Ltd. | INDUSTRY |
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This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD7 Chimeric Antigen Receptor-T(CAR-T) therapy for patients with CD7-positive relapsed or refractory T-Acute Lymphoblastic Leukemia(ALL)/Lymphoblastic Lymphoma(LBL)/Acute Myelogenous Leukemia(AML), and to evaluate the pharmacokinetics of CD7 CAR-T in patients。
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RD13-02 cell infusion | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RD13-02 cell infusion | Drug | CAR-T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) | Evaluate at 4 weeks after CAR-T infusion |
| Overall response rate (ORR) | The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) | Evaluate at 8 weeks after CAR-T infusion |
| Overall response rate (ORR) | The proportion of patients with complete response (CR) /complete response with incomplete blood cell recovery (CRi) | Evaluate at 12 weeks after CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate , ORR | The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and partial response (PR). | Up to 1 years after CAR-T infusion |
| Overall response rate with Minimal Residual Disease (MRD)-negative, MRD-ORR |
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Inclusion Criteria:
Exclusion Criteria:
14.Having received live/attenuated vaccine within 4 weeks prior to screening. 15.History of allergy to any component of the cell therapy product. 16.Pregnant or breastfeeding women 17.Any other issue which, in the opinion of the investigator, would make the subjects ineligible for the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital, Huazhong University of Science and Technology | Wuhan | Hubei | 430022 | China |
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Proportion of patients achieving CR/CRi who is MRD-negative in bone marrow |
| Up to 1 years after CAR-T infusion |
| Duration of remission (DOR) | The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion | Up to 1 years after CAR-T infusion |
| Event-free survival (EFS) | The time from first achieving CR/CRi to relapse or death | Up to 1 years after CAR-T infusion |
| The proportion of patients who receive hematopoietic stem cell transplantation | The proportion of subjects who achieved remission after infusion who received Hematopoietic Stem Cell Transplantation (HSCT) | Up to 1 years after CAR-T infusion |
| Overall survival (OS) | The time from CAR-T infusion to death due to any cause | Up to 1 years after CAR-T infusion |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006425 | Hemic and Lymphatic Diseases |
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